Benefits of AstraZeneca Vaccine Outweigh Risks, Say EMA and WHO Officials – Urging Jabs to Continue as Safety Data Reviewed Medicines & Vaccines 12/03/2021 • Madeleine Hoecklin Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) The AstraZeneca vaccine being administered in Catalonia, Spain in mid-February. Both the European Medicines Agency and the World Health Organization have urged that immunizations with the Oxford/AstraZeneca COVID-19 vaccine continue – despite a decision by several European countries to suspend its use – after reports of serious blood clots among 30 of the 5 million people vaccinated – leading to at least five deaths. An EMA statement said that the inoculations can continue while the investigation is underway. “There is currently no indication that vaccination has caused these conditions,” said the EMA in a press release. “The position of EMA’s safety committee PRAC is that the vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered.” Preliminary view from EMA’s safety committee (#PRAC): there is no specific issue with a batch of #COVID19 Vaccine AstraZeneca that has been suspended in Austria after cases of multiple thrombosis were reported. 👉https://t.co/292s0fSNJs pic.twitter.com/lh3BXG4e1m — EU Medicines Agency (@EMA_News) March 10, 2021 In addition, the number of cases of blood clots doesn’t exceed the cases in the general population, the EMA said. This message was echoed by a WHO spokesperson, Margaret Harris, who called the pause of the vaccine a “precautionary measure,” saying that no causal relationship has been established yet. “It is very important we are hearing safety signals because if we were not hearing about safety signals that would suggest there is not enough review and vigilance,” said Harris at a media briefing on Friday. “Any safety signal must be investigated.” Some 30 cases of blood clots have been reported among the 5 million people vaccinated in the European Economic Area with the AstraZeneca vaccine, as of Thursday. This includes one death in Austria, one in Denmark, one in Bulgaria, and two in Italy. Ten EU Countries Temporarily Pause Vaccinations, While Others Push Ahead Denmark, Norway, Iceland and Bulgaria are pausing all AstraZeneca vaccinations, while Austria, Italy, Estonia, Latvia, Luxembourg and Lithuania are blocking further use of doses from the most recent batch of vaccines. The batch of one million doses was delivered to 17 EU countries. A full investigation conducted by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is ongoing and it will evaluate the batch quality, along with all reported cases of post-vaccination blood clots with the AstraZeneca vaccine. A WHO advisory committee on vaccine safety is also currently reviewing the reports. “It’s very important to understand that…we should continue to be using the AstraZeneca vaccine,” said Harris, calling it an “excellent vaccine.” Germany, France and the United Kingdom have decided to continue with their rollout of the vaccine, reaffirming the safety and efficacy of the jab. Germany and France are facing a scarcity of vaccines and a rise in infection rates. Suspending the AstraZeneca vaccine could undermine their already struggling vaccination efforts. “Everything we know so far suggests that the benefits of the vaccine, even after every individual case reported, are greater than the risks, and that continues to be the case,” said Jens Spahn, Germany’s health minister, at a news briefing on Friday. “Available evidence does not confirm that the vaccine is the cause,” said Phil Bryan, vaccine safety lead of the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Investigation Into Blood Clots As Possible Vaccine Side Effect A package of 10 multidose vials of the Oxford/AstraZeneca COVID-19 vaccine. National health agencies in the EU countries that have paused the use of some or all AstraZeneca vaccines have emphasized their need to examine and clarify the possible serious side effects before resuming with vaccinations. “It is currently not possible to conclude whether there is a link,” said Magnus Heunicke, the Danish health minister, on Twitter. “We are acting early, it needs to be thoroughly investigated.” Five deaths have been reported among individuals who were inoculated from the same batch of AstraZeneca vaccine doses. A 49 year old nurse in Austria died of blood coagulation problems, a 60 year old woman in Denmark formed a fatal blood clot, a 57 year old woman in Bulgaria died of heart failure, and two police officers in Italy, aged 43 and 50, died of severe coagulation disorders. Following the news of the suspension of vaccination programs, Thailand announced its decision to delay the rollout of the AstraZeneca vaccine, which was set to begin on Friday. “We are delaying to let others prove [the side effects] of whether or not it is because of the vaccine or if it is only on that specific batch,” Yong Poovarawan, a Thai virologist, told the Guardian. “We are waiting for Denmark and Austria to make a conclusion.” Blood clots were not listed as possible side effects from the vaccine and no pattern of serious adverse events provided a safety signal, according to clinical trial results. “An analysis of our safety data of more than 10 million records has shown no evidence of an increased risk of pulmonary embolism or deep vein thrombosis in any defined age group, gender, batch or in any particular country,” Gonzalo Viña, a spokesperson for AstraZeneca, told the New York Times. EMA To Review Bleeding and Bruising Issues Associated With Three Vaccines In sharp contrast, to the reports of clotting, there also have been reported side effects of bleeding and bruising from both the AstraZeneca vaccine as well as Pfizer’s and Moderna’s. The EMA announced on Friday that the PRAC started a review of reports of immune thrombocytopenia – a disorder of low levels of blood platelets that can lead to bruising and bleeding – for those three EMA authorized COVID-19 vaccines. Following reports of several cases of immune thrombocytopenia, case reports and clinical trial data from Pfizer/BioNTech, AstraZeneca, and Moderna will be gathered to determine if there is a causal relationship. “At this stage, it is not yet clear whether there is a causal association between vaccination and the reports of immune thrombocytopenia,” said the EMA in a press release. “These reports point to a ‘safety signal’ – information on new or changed adverse events that may potentially be associated with a medicine and that warrants further investigation.” In a separate investigation, the EMA concluded that a link between severe allergic reactions and the AstraZeneca vaccine was “likely in at least some of [the 41 cases of anaphylaxis].” This finding comes after the Agency reviewed the 41 reports that emerged among five million vaccinations in the UK. The EMA is recommending an update to AstraZeneca’s vaccine product information to add to the existing warning of anaphylaxis and hypersensitivity as side effects. According to the EMA, any individual that develops a severe allergic reaction to the first dose of the vaccine shouldn’t be given a second dose. AstraZeneca to Delay Vaccine Deliveries to EU Again, Risking Restarting Feud with EU Meanwhile, AstraZeneca is reportedly facing difficulties with its international supply chains and expects to deliver 30 million doses to the EU by the end of March – 10 million less than it pledged in February and a third of its contractual obligation, according to a document seen by Reuters. The pharma company risks angering EU officials once again by scaling back vaccine deliveries, adding to the EU’s problem of vaccine scarcity. AstraZeneca’s manufacturing and delivery efforts were described as “not good enough” by Thierry Breton, EU Commissioner on internal market. AstraZeneca #vaccines delivery : I see efforts, but not “best efforts”. That’s not good enough yet for @AstraZeneca to meet its Q1 obligations. It’s time for AstraZeneca’s Board to exercise its fiduciary #responsibility and now do what it takes to fulfil AZ’s commitments. — Thierry Breton (@ThierryBreton) March 11, 2021 AstraZeneca said it expects to ship doses produced in the US – where some 30 millions of doses are in manufacturing facilities, waiting for the US Food and Drug Administration’s (FDA) authorization – to the EU. The FDA won’t make a decision on the vaccine until the US late-stage clinical trial is complete, which may take another month. “We understand other governments may have reached out to the US government about donation of AstraZeneca doses, and we’ve asked the US government to give thoughtful consideration to these requests,” said Viña to the New York Times. The Biden Administration, however, has denied these requests for the near future. “If we have a surplus, we’re going to share it with the rest of the world,” said President Joe Biden to reporters on Wednesday. “We’re going to start off making sure Americans are taken care of first.” The US’ hesitancy to export vaccines was criticized by Charles Michel, President of the European Council, who said in a statement that the US and UK have “imposed an outright ban on the export of vaccines or vaccine components produced on their territory…[while] the EU has never stopped exporting.” Image Credits: Flickr, Flickr, Flickr. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. 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